ICN Pharmaceuticals, Inc. v. Canada ( Patented Medicines Prices Review Board )
T-2541-95
Cullen J.
15/2/96
18 pp.
Judicial review of Board's decision within its jurisdiction to consider whether prices applicants charged for ribavirin, under brand name Virazole, excessive-Board responsible for ensuring prices charged in Canada for patented medicines not excessive-Based on information obtained from patentee concerning identity of medicines, prices, costs of marketing, making medicine, Board having authority to determine whether prices charged for medicine excessive-Patent Act, s. 83(1) providing where Board finding patentee of invention pertaining to medicine selling medicine at excessive price, may order patentee to reduce maximum price at which selling medicine to specified level-S. 79(2) providing "invention pertaining to a medicine" if invention intended or capable of being used for medicine or for preparation or production of medicine-Patent '264 granted to ICN Pharmaceuticals describing enzymatic process for preparing ribavirin, active ingredient in medicine sold as "Virazole"-Patent '265 granted to Viratech Inc. pertaining to various methods of medical treatment utilizing ribavirin-Board concluding both patents relating to Virazole, had jurisdiction-Application dismissed-Expert nature of Board indicating curial deference in order, but on jurisdictional issue of whether '264, '265 patents intended or capable of being used for medicine or for preparation, production of medicine, standard of review correctness-'264 patent capable of preparing medicine although not useable to create suitable quantities of ribavirin, and not intended by patentee to be used to create industrial quantities of ribavirin-"Capable" in context of Patent Act not meaning "commercially feasible" or "reasonably practicable"-Patent Act, ss. 79 to 103 creating Patented Medicine Prices Review Board enacted in response to abolition of compulsory licensing regime-Parliament's intent to address "mischief" that patentee's monopoly over pharmaceuticals during exclusivity period might cause prices to rise to unacceptable levels-Words of these sections should be read purposively, acknowledging Board's jurisdiction over all patents either intended or capable of preparing or producing medicine, not only those patentee insisting using or deeming feasible-Such restrictive interpretation not meshing with legislative scheme, which does not provide Board any powers to investigate patentee's conduct or actual use of patent-Patentee could avoid Board's jurisdiction simply by asserting not using patented process because commercially infeasible or raw materials not available-'264 patent within Board's jurisdiction-'265 patent comprising uses for ribavirin and ribavirin medicine-"Medicine" in s. 79(2) not meaning only drug as described in product monograph and for which NOC issued-"Medicine" in s. 79(2) given same interpretation as under former compulsory licensing provisions of Patent Act-Phrase "intended or capable of being used for medicine or for preparation or production of medicine" including all medicines, not only those sold pursuant to NOC-Board correctly finding should not go beyond face of patent and construe claims to determine if corresponded to NOC for Virazole-On its face, '265 patent intended for preparation or production of medicine-That finding alone establishing Board's jurisdiction-Subsequent to hearing, decision by Board, applicants filing disclaimer specifically disclaiming any claims to any invention in relation to indications for which Virazole approved for sale in Canada-Even if disclaimer valid, Board's authority not terminating because invention disclosed by '265 patent continuing to pertain to ribavirin within meaning of s. 79(2)-Patent disclosed uses, and intended to be used in preparation or production of medicine, including medicines not available for sale pursuant to NOC-Disclaimer invalid-S. 48(4) providing "No disclaimer affects any action pending at the time when it is made, unless there is unreasonable neglect or delay in making it"-Patent Act, R.S.C., 1985, c. P-4, ss. 48(4), 79(2) (as am. by S.C. 1993, c. 2, s. 7), 83(1) (as am. idem), 85 (as enacted idem).